SUPPLY CHAIN ARTICLES
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![Teamwok-GettyImages-1411776159]( "4 Risk Mitigation Strategies For mRNA Production")
4 Risk Mitigation Strategies For mRNA ProductionPlanning and procuring custom materials needed to manufacture mRNA remains a top concern. This article shares risk mitigation strategies for multi-sourcing, S&OP process, packaging size, and material expiry.
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![Key takeaways-GettyImages-1659816694]( "Plasmid Production: 3 Key Takeaways For mRNA Manufacturing")
Plasmid Production: 3 Key Takeaways For mRNA ManufacturingFollowing my latest Live panel on analytical and manufacturing technology innovations for mRNA production, I wanted to provide a few high-level takeaways I gleaned from our discussion on the overlooked darling of the mRNA space: The plasmid.
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![Bottleneck-GettyImages-466101013]( "The Cell-Free Revolution: Breaking The Plasmid DNA Bottleneck")
The Cell-Free Revolution: Breaking The Plasmid DNA BottleneckI was excited to be given the opportunity to sit down with Jodi Barrientos, CEO, Ribbon Bio, to learn more about the current state of the synthetic DNA space. In the following Q&A, Barrientos and I discuss some of the synthetic DNA industry’s biggest goals and the challenges that stand in the way of bringing synthetic plasmids more commonly into the mRNA development paradigm.
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![Man working in vegetable garden-GettyImages-1327986655]( "Cultivating A Thriving mRNA Ecosystem: Key Initiatives & Future Directions")
Cultivating A Thriving mRNA Ecosystem: Key Initiatives & Future DirectionsOverall, I felt that the following initiatives/talking points were demonstrative of the types of creativity and symbiosis that we will need much more of in the near and long-term to foster a healthy and fruitful RNA ecosystem.
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![biotechnology, Global Networking, Research, Development, Innovation, Advancing Smart Solutions-GettyImages-2123154659]( "Innovations In The Oligonucleotide Supply Chain: Regulatory Considerations For Materials, Manufacturing, And Lifecycle Control")
Innovations In The Oligonucleotide Supply Chain: Regulatory Considerations For Materials, Manufacturing, And Lifecycle ControlOligonucleotide therapeutics have rapidly advanced into late-stage and commercial development, shifting regulatory focus toward the maturity of manufacturing and supply chain control rather than therapeutic novelty. Regulatory success now depends on how effectively sponsors translate innovative chemistries into well-characterized, scalable, and sustainable materials and processes.
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![GettyImages-96831350]( "“To Thine Own [mRNA Product] Be True:” Shakespeare's Guide To RNA GMP Principles")
“To Thine Own [mRNA Product] Be True:” Shakespeare's Guide To RNA GMP PrinciplesIn the following article, I offer some of the biggest tips and tricks experts offered during a panel discussion on the challenges of navigating GMP principles in the RNA space today — with a little bit of help from Shakespeare himself.
SUPPLY CHAIN VIDEOS
Large scale production of plasmid DNA requires an in-depth understanding and optimization of the entire downstream process. Explore a complete solution, from harvest to bulk filtration.
What challenges do you consider the most formidable in your own mRNA therapeutic development environments?
Learn more about CustomBiotech's mRNA raw materials pipeline and strict quality criteria that are designed to support the success of our customers’ manufacturing scale-up and regulatory drug approval.
Together, Life Edit Therapeutics’ April Sena and Sanofi’s Troiano share their perspectives on raw material quality & IP-related considerations for managing the supply chain for next-generation RNA modalities.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-523692032]( "Moderna's Regulatory Journey: 3 Takeaways To Foster The mRNA Renaissance")
The story of how Moderna brought one of the first mRNA vaccines to the market has all the makings of a legend we will pass down through generations. However, unlike the legends of King Arthur or The Fountain of Youth, we can celebrate that Moderna’s legendary journey was — and still is — real. Not only did the mRNA vaccines help return life to normal, but they also kickstarted the mRNA therapeutic renaissance we’re happily experiencing today.
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![GettyImages-1212392754-petri-bacteria-plasmid-lab]( "The Role Of CRISPR Cas9 Plasmids In Gene-Editing")
Plasmids are crucial for CRISPR-Cas9 gene-editing technology, and their role in CRISPR is expected to evolve with ongoing research.
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![iStock-1155553590-syringe-glove-doctor-vaccine-medicine]( "Overcome Vaccine Development Complexities With The Right Supply Chain Partner")
Explore the challenges impacting clinical supply chains and solutions to overcome these complexities, and understand why it is crucial to pick the right supply chain provider for vaccine storage and distribution.
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![Warehouse management innovative software GettyImages-1355815870]( "Reducing Lead Time, Delivering >99.5% OTIF")
Explore the stocking solution offered to a mid-sized CDMO in need of a high volume of safety stock inventory to support their customer portfolio growth.
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![GettyImages-1317697233-cancer-t-cells]( "A Novel RNA Lipid Nanoparticle Platform: Gene-Edited CAR T Cells For Off-The-Shelf Cancer Therapy")
We report on the use of a novel lipid nanoparticle (LNP) reagent in a validated protocol to achieve successful complex gene editing in primary T cells with high efficiency while maintaining high cell viability.
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![Merck Building-shmear]( "Biopharma Supply, Reimagined: Regional, Resilient Manufacturing")
Persistent disruption is redefining biopharma supply chains. Explore how regional manufacturing, integrated risk management, and closer collaboration help build resilience and improve agility.
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![Scientists laboratory pipette GettyImages-621351044]( "Eliminating Antibiotic Resistance Gene Transfer Risks In CGTs")
Learn about the drawbacks of antibiotic resistance that can cause side effects in patients and how an antibiotic-free approach can ease the burden of regulatory compliance and accelerate development.
